INSTAFLEX EXTRA STRENGTH PAIN RELIEF CREAM- menthol, methyl salicylate cream

Instaflex Extra Strength Pain Relief Cream by

Drug Labeling and Warnings

Instaflex Extra Strength Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Healthy Directions, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts 

ACTIVE INGREDIENT

Active Ingredients

Menthol (2.5%)

Methyl Salicylate (10%) 

PURPOSE

Purpose

Topical Analgesic 

INDICATIONS & USAGE

Uses Temporarily relieves minor aches and pains of muscles

and joints associated with: 

• simple backache
• arthritis 
• strains 
• sprains 
• bruises

WARNINGS

Warnings

For external use only

Do not use

• with a heating pad, may blister skin
• on open wounds or damaged skin 

Ask a doctor before use if you have

redness over the affected area

When using this product

• Use only as directed 
• avoid contact with eyes 
• do not bandage tightly

Stop use and ask a doctor if

• skin redness or excessive skin irritation develops
• condition worsens or symptoms persist for more than 7 days 
• symptoms clear up and occur again in a few days 

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away. 

DOSAGE & ADMINISTRATION

Directions Adults and children 12 years of

age and older: Apply to affected area no more than

3-4 times daily. Children under 12 years of age:

Consult a doctor. 

STORAGE AND HANDLING

Other Information Keep product at room termperature and

humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. For Lot

Number and Expiration Date, see crimp at end of tube. 

INACTIVE INGREDIENT

Inactive ingredients C13-14 Isoparaffin, Citrus Aurantium

Dulcis (Orange) Oil, Ethylhexlglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxygenated Corn Oil, PEG-100

Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Water 

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH PAIN RELIEVING CREAM

Instaflex 

PAIN RELIEF

Formulated with an 

EXCLUSIVE OXYGENATED OIL 

FAST, EXTRA STRENGTH RELIEF FOR

ARTHRITIS, JOINT & MUSCLE PAIN 

DOUBLE THE PAIN-FIGHTING INGREDIENTS

DOUBLE THE MENTHOL POWER*

Deep Penetrating |  Fast Acting |  Great for Nighttime Use 

EXTRA STRENGTH | DOCTOR DEVELOPED 

Net wt. [2/4] oz ([57/113] g) 

INGREDIENTS AND APPEARANCE

INSTAFLEX EXTRA STRENGTH PAIN RELIEF CREAM 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70015-660
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	25 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ORANGE OIL (UNII: AKN3KSD11B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-7 (UNII: Z95S6G8201)
CORN OIL (UNII: 8470G57WFM)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70015-660-02	1 in 1 CARTON	03/01/2019
1		57 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70015-660-04	1 in 1 CARTON	03/01/2019
2		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2019

Labeler - Healthy Directions, LLC (150261183)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(70015-660)